Product image of Nizoral (Ketoconazole) supplied by GNH India

Nizoral

Active Ingredient:
Ketoconazole
Origin:
EU

Nizoral (Ketoconazole)

Ketoconazole, the active ingredient in Nizoral, is an azole antifungal presented as a topical formulation for skin application. It is used to treat fungal infections of the skin and scalp in adults and children. The medication is formulated for external use and is indicated for a range of dermatophyte and yeast infections, providing localized antifungal activity with minimal systemic absorption.

GNH India supplies Nizoral as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and research institutions worldwide.

Manufacturer / TM Owner

Stada Arzneimittel Ag

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Indications & Clinical Uses

Ketoconazole is an azole antifungal that targets fungal cell membrane synthesis, making it effective for several skin conditions.

  • Seborrheic dermatitis: reduces scaling and erythema on the scalp and face.
  • Tinea corporis (ringworm): clears the fungal infection on the body.
  • Tinea cruris (jock itch): alleviates itching and rash in the groin area.
  • Tinea pedis (athlete's foot): treats fungal infection of the feet.
  • Pityriasis versicolor: eliminates yeast overgrowth causing discolored patches.

How It Works

  • Ketoconazole inhibits the fungal enzyme lanosterol 14α‑demethylase, a key step in ergosterol synthesis. By blocking this pathway, the drug disrupts the integrity of the fungal cell membrane, leading to increased permeability and ultimately cell death. The action is localized when applied topically, resulting in minimal systemic exposure.

Side Effects

Topical ketoconazole may cause local and, rarely, systemic adverse reactions.

Common Side Effects

  • Skin irritation: mild burning or stinging at the application site.
  • Itching: transient pruritus after use.
  • Dryness: localized skin dryness or flaking.
  • Redness: erythema around the treated area.

Serious or Rare Side Effects

  • Severe allergic reaction: swelling, hives, or difficulty breathing.
  • Stevens‑Johnson syndrome: rare but serious skin blistering.
  • Hepatotoxicity: systemic absorption may rarely affect liver function.
  • Photosensitivity: increased sensitivity to sunlight.
  • Contact dermatitis: allergic skin inflammation.

Precautions & Warnings

When using Nizoral, consider the following precautions to ensure safe and effective treatment.

  • Avoid application on broken or inflamed skin: may increase irritation.
  • Do not apply near eyes or mucous membranes: can cause severe irritation.
  • Discontinue use if severe redness or swelling occurs: seek medical advice.
  • Use with caution in patients with liver disease: systemic absorption may be higher.
  • Avoid concurrent use with other topical antifungals unless directed: risk of increased irritation.
  • Store at room temperature: keep in original container, protect from moisture and heat.

Avoid Interactions

Ketoconazole can interact with certain systemic and topical agents; awareness helps prevent adverse effects.

Major Interactions (Avoid)

  • Concurrent oral azole antifungals (e.g., itraconazole): may lead to excessive systemic exposure.
  • Topical corticosteroids applied over ketoconazole: can increase skin irritation.
  • Warfarin therapy: systemic absorption may potentiate anticoagulant effect.
  • Hepatotoxic drugs (e.g., isoniazid): combined use may increase liver risk.

Moderate Interactions (Monitor Closely)

  • Other topical antifungal agents: monitor for cumulative irritation.
  • Photosensitizing agents: advise sun protection.
  • Systemic CYP3A4 inhibitors (e.g., erythromycin): monitor liver function if systemic absorption occurs.

Frequently Asked Questions

Nizoral contains ketoconazole, an azole antifungal that is applied topically to treat skin and scalp fungal infections such as seborrheic dermatitis, tinea corporis, tinea cruris, tinea pedis, and pityriasis versicolor. It works by eliminating the fungi that cause these conditions, helping to reduce symptoms like scaling, itching, and redness.

Ketoconazole blocks the fungal enzyme lanosterol 14α‑demethylase, which is essential for producing ergosterol, a key component of the fungal cell membrane. Without ergosterol, the membrane becomes unstable, leading to leakage of cellular contents and death of the fungus. This mechanism provides targeted antifungal activity when the drug is applied to the skin.

The dosage of Nizoral is determined by the prescribing healthcare professional based on the specific infection, its severity, patient age, and other clinical factors. The prescriber will provide instructions on how much product to apply, the frequency of application, and the total duration of therapy.

Safety data for topical ketoconazole in pregnancy and lactation are limited. Healthcare providers usually weigh the potential benefits against any possible risks before prescribing. Women who are pregnant, planning to become pregnant, or breastfeeding should discuss the use of Nizoral with their doctor to determine if it is appropriate for their situation.

To request Nizoral, visit the product page on gnhindia.com and submit an enquiry with the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, confirming trade or institutional credentials before providing pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Nizoral (ketoconazole) belongs to the azole class, which differs from allylamine agents like terbinafine. Azoles inhibit ergosterol synthesis, while allylamines block a different step in the same pathway. Ketoconazole is often chosen for its broad spectrum against dermatophytes and yeasts, whereas other agents may be preferred for specific organisms or resistance patterns.

Nizoral should be stored at room temperature, typically below 25 °C (77 °F). Keep the product in its original packaging, protect it from moisture, direct sunlight, and excessive heat to maintain stability and effectiveness throughout its shelf life.

Nizoral is applied topically to the affected skin area. Clean and dry the skin, then spread a thin layer of the cream or lotion as directed by the prescriber, usually once or twice daily. Avoid contact with eyes, mouth, and open wounds unless specifically instructed.

Serious risks, though rare, include severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, and systemic hepatotoxicity if significant absorption occurs. Patients should stop using the product and seek immediate medical attention if they experience swelling, difficulty breathing, widespread rash, or signs of liver dysfunction.

Individuals with known hypersensitivity to ketoconazole, other azole antifungals, or any component of the formulation should avoid Nizoral. It is also contraindicated on severely damaged or inflamed skin, and caution is advised for patients with existing liver disease or those taking hepatotoxic medications.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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